Cleared Traditional

K231552 - Dia-Cem (FDA 510(k) Clearance)

K231552 · DiaDent Group International · Dental device

Jul 2023

Decision

59d

Days

Class 2

Risk

K231552 is an FDA 510(k) clearance for the Dia-Cem. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by DiaDent Group International (Cheongju-Si, KR). The FDA issued a Cleared decision on July 28, 2023, 59 days after receiving the submission on May 30, 2023.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K231552 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 30, 2023
Decision Date	July 28, 2023
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF